Method for detecting Anti-drug antibodies

a technology of anti-drug antibodies and detection methods, which is applied in the direction of measurement devices, instruments, material testing goods, etc., can solve the problems of reducing the efficacy of biopharmaceuticals, wasting considerable expenditure on ineffective therapy, and losing time in the treatment of disorders, etc., and achieves high efficacy and sensitive

Inactive Publication Date: 2013-08-08
BIOMONITOR
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AI Technical Summary

Benefits of technology

[0014]The present invention provides a highly effective and sensitive assay for detection of the in vivo ADA against bio-agents, such a

Problems solved by technology

The widespread use of biopharmaceuticals raises the possibility that some patients may develop antibodies to the drugs, which can greatly decrease the efficacy of the (biopharmaceutical) drug, or completely obliterate the benefit of taking the drug, resulting in considerable wasted expenditure on ineffective therapy, and more importantly, lost time in the treatment of the disorder which can have catastrophic effects in terms of the development of disease and disorders in the patient.
Indeed, response failure due to induction of antibodies (Abs) against biopharmaceuticals is increasingly being realized.
The development of host antibodies can be remedied by increasing dosage—although this is typically a delayed and rather temporary response as the prescription dosage is typically only increased once patient symptoms noticeably deteriorate, and the increased dosage may well result in further augmentation of the patients immune system.
The development of host (patient) antibodies against biopharmaceutical use is particularly of issue when the drug is delivered chronically, i.e. periodic administration over a period of months or years.
All of these proteins dramatically lower disease activity and, in some patients, may induce remission.
Unfortunately, however, not all patients respond favorably to anti-TNF antibodies.
Some patients either do not respond at all (primary response failure) or they respond initially but have later relapses (secondary response failure) despite increased dosage and/

Method used

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Examples

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example 1

Assay for ADA Against Human Monoclonal Ab Constructs

Principle:

[0162]1) ELISA-plate or other solid phase for fixation of Ig-binding molecules (See FIG. 1A). The Ig-binding molecules can be ex. anti-Ig (Fc-specific or Fab specific), protein A, protein G, protein H or similar reagents. Washing is preferably made between each new manipulation. Fixation can be non- or covalent.

[0163]All binding sites are then blocked by an unspecific reagent not interfering with the Ig-binding capacity of the fixed Ig-binding reagent.

[0164]2) Binding of serum / plasma Ig (see FIG. 1B)

[0165]3) Blockade of Ig-binding sites on the fixed Ig-binding molecules, by adding non-labeled non-ADA Ig, before or together with the labelled human monoclonal Ig construct (see FIG. 1C).

[0166]4) Measurement of the bound label by standard methods.

example 2

Detailed Protocol for ADA Assay

[0167]Example: EIA for ADA Against Infliximab (anti-TNFa IgG)[0168]1) Coat: 25 μg / ml of protein G in PBS, 100 μL / well on a 96-well flat bottom plastic plate, followed by 18-36 h incubation at 4-8 C.[0169]2) Wash the wells manually or by a plate washer with PBS+0.05% Tween 20[0170]3) Block of residual binding sites by PBS+2% BSA or Superblock (Pierce cat#37515) 2 h at room temperature or 18-24 at 4-8 C[0171]4) Wash the wells manually or by a plate washer with PBS+0.05% Tween 20[0172]5) Sample: Serum / plasma is added at 100 μl / well diluted to ex. 0.25% in PBS+5 mM EDTA+1% human serum albumin, or if further diluted, diluted in PBS+5 mM EDTA+1% human serum albumin with or without 0.25% pooled normal human serum. Incubate 18-24 h at 4-8 C.[0173]6) Wash the wells manually or by a plate washer with PBS+0.05% Tween 20.[0174]7) Ad 100 μl / well of Biotin labelled Infliximab, at ex. 40 ng / ml of PBS+1% human serum albumin+4% pooled normal human serum. Incubate 2-3 h...

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Abstract

The present inventions relates to the monitoring or assaying of anti-bio-agent antibodies, such as anti-drug antibodies (ADA) in patients who may have developed an antibody response in treatments with immunoglobulin bio-agents.

Description

FIELD OF THE INVENTION[0001]The present inventions relates to the monitoring or assaying of anti-bio-agent antibodies, such as anti-drug antibodies (ADA) in patients who may have developed an antibody response in treatments with immunoglobulin bio-agents.BACKGROUND OF THE INVENTION[0002]According to the Pharmaceutical Research and Manufacturers of America (PhRMA) millions of people have benefited from medicines and vaccines developed through biotechnology, and according to recent reports there are numerous further biopharmaceuticals for the treatment of more than 100 diseases currently in development. In their survey, the PhRMA identifies 324 biotechnology medicines in development for nearly 150 diseases. These include 154 medicines for cancer, 43 for infectious diseases, 26 for autoimmune diseases and 17 for AIDS / HIV and related conditions. These potential medicines, all of which are either in human clinical trials or under review by the Food and Drug Administration, will bolster t...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/564G01N2800/52G01N33/6854
Inventor SVENSON, MORTENBOVIN, LONE FRIER
Owner BIOMONITOR
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